FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
- Recall number
- Z-2591-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
- Status
- Terminated
- Initiated
- 2017-05-08
- Posted
- not on file
- Terminated
- 2019-08-08
- Reason
- When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
- Root cause
- Software design (manufacturing process)
- Action
- Merge sent an Urgent Medical Device Recall letter dated May 5, 2017, to all affected customers. Customers were instructed to be aware of the following workaround: Do not have the simple close study red x icon available in the reading physicians toolbars. This will force them to set status on close which also presents the warning Not all images have been reviewed, do you want to set status anyway and close study or continue reviewing unviewed images? YOUR RESPONSE TO THIS NOTIFICATION IS REQUIRED By replying to this notification, you will be taking the necessary steps to ensure that the issue listed in this document will be resolved. Please reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 877-741-6369.
- Quantity
- 47 sites have the potentially affected versions
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
- 510(k) numbers
- ["K082144"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28